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FDA 510(k)

faceLITE

K-Number: K191629 · 2019-09-12

ApplicantIsmart Marketing Svcs, Ltd.
Decision Date2019-09-12
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

faceLITE is a medical device manufactured by Ismart Marketing Svcs, Ltd.. It received FDA 510(k) clearance on 2019-09-12 under approval number K191629. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the faceLITE?

faceLITE is a medical device that received FDA 510(k) clearance on 2019-09-12. It is manufactured by Ismart Marketing Svcs, Ltd.. The 510(k) number is K191629.

When was faceLITE approved by the FDA?

faceLITE received FDA 510(k) clearance on 2019-09-12, under approval number K191629.

What company makes faceLITE?

faceLITE is manufactured by Ismart Marketing Svcs, Ltd..

What is the FDA product code for faceLITE?

The FDA product code for faceLITE is OHS.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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